Federal Register - October 1, 2021

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Fuente: Federal Register

54570

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
Parrado would occasionally provide more summary or conclusory opinions to the questions posed to him. For example, Mr. Parrado gave the blanket conclusory opinion that based on the discussions between Mr. Parrado and Mr. Sprys and Ms. Mincy, of which there was no record or report, Mr.
Parrado opined that in every instance of a red flag, they properly resolved the red flag prior to dispensing the subject controlled substance.
There were also a number of disagreements between Dr. Hamilton and Mr. Parrado in a number of areas, which will be discussed infra.
However, Mr. Parrados testimony was diminished by his failure to include important details as to the bases of his opinions in this matter. First, Mr.
Parrado failed to disclose that he interviewed Mr. Sprys and Ms. Mincy in forming his opinions in this matter. Tr.
497500, 50406. As bases for his opinions and having testified as an expert in a number of these proceedings, Ms. Parrado should be well aware of his obligations and the necessity to disclose the bases of his opinions, particularly if interviewing witnesses in this matter formed the bases of his opinions. My Order for Prehearing Statements specifically requires witnesses who rely on hearsay statements to identify those individuals in the prehearing statement.
ALJ Ex. 3. Mr. Parrados opinions were further diminished by the fact that Mr.
Sprys did not testify, so he could not be subject to cross-examination on this issue. Therefore, Mr. Parrados subject opinions are based on hearsay statements that were not subject to cross-examination. The Government was given an opportunity to cross examine Ms. Mincy. Additionally, Mr.
Parrado testified that Ms. Mincy and Mr.
Sprys confirmed to him that checking the EFORCSE database was instrumental in their resolving certain red flags. As GX 38 reveals, Mr. Sprys and Ms. Mincys access of the E
FORCSE was not as diligent as claimed.
See infra section Opioid Tolerance High Starting Dosages. This suggests that Mr. Parrados opinions in this regard are diminished by less than reliable claims made to him by Mr.
Sprys and Ms. Mincy. Additionally, as there was little or no documentary support for Mr. Sprys and Ms. Mincys claims to Mr. Parrado that they appropriately resolved each of the subject red flags, one would have to credit them with extraordinary memory, based on specific events over a few year period which the record does not establish.
Secondly, when cross-examined about his conclusions regarding the distance
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traveled by Patient A.R., Mr. Parrado was asked why he did not provide certain details about his opinions in his expert report. Tr. 54041. When asked why he didnt put anything in his report about the pharmacists relationship with Patient A.R., he stated I didnt see cause for that. My eloquence is not that great. These statements further diminish Mr. Parrados bases for his opinions in this matter. Further, there was an inconsistency in Mr. Parrados evaluation. In defending the Respondents resolution of red flags, Mr.
Parrado often relied on the PRM records maintained in the pharmacy file to justify the resolution. However, in instances where the PRM did not establish justification of the red flag, Mr.
Parrado dismissed this fact and credited the Respondents resolution by virtue of the mere effort of contacting the physician. This is contrary to the pharmacists corresponding responsibility. The pharmacist must resolve red flags. An unsuccessful attempt to resolve red flags is insufficient.
However, overall, I do not find that Mr. Parrado was disingenuous or lacking candor in his testimony, even when he occasionally failed to answer questions in a direct manner or to provide notice of all facts and materials upon which he relied in making his opinions. I do find his testimony to be generally credible and reliable, to the extent the information upon which he relied was accurate.
As to both experts in this matter, I
consider their opinions and the merits of each when weighing the factors and the law. Here, the experts had differing strengths. Mr. Parrado has a tremendous amount of experience in Florida Pharmacy law and practice, while Dr.
Hamilton seems to have the edge regarding existing pharmacy practice and market forces. However, as with any battle of experts, it is the experts justification, or explanation for his opinion, which is key. As developed in detail infra, generally Dr. Hamiltons justifications and explanations for his opinions appeared more consistent with existing market forces, the relevant law, and Agency precedent than those of Mr.
Parrado.
Omitted for clarity.
Conflicting Findings of Dr. Hamilton and Mr. Parrado Florida Minimum Standard of Care Dr. Hamilton provided testimony that he understood the Florida minimum standard of care to be guided by the Florida Administrative Code, specifically Regulation 64B and
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guidelines provided by the National Board of Pharmacy Association. Tr.
18081. Specifically, Dr. Hamilton noted that the Florida standard of care included responsibilities not specifically included within the relevant Florida regulations. Id. at 1007
08. On the other hand, Mr. Parrado testified that he understood the minimum standard of care to be set strictly and exclusively by the Florida Pharmacy Act or the Florida Administrative Code. Id. at 456. Further, the experience that Mr. Parrado has in the creation and implementation of these standards give his testimony significant weight in determining the import and scope of Florida law.GG
A careful review of Florida law and regulations guiding the practice of pharmacy within the State of Florida shows that the practice is generally guided by Chapter 465 of the Florida Pharmacy Act,55 and Florida Administrative Code rule 64B16, which governs pharmacy practice. Based strictly on this review, Mr. Parrados testimony as to the law and regulations governing the practice of pharmacy in Florida appears to be correct. While Dr.
Hamilton may also be correct about the guidelines set by the National Board of Pharmacy Association that have guided the State of Florida in its implementation of laws and regulations setting the minimum standard of care, it cannot be ascertained from the literal text of relevant Florida regulations where the Associations guidelines have been given any legal force beyond those provided for in the statutes and regulations cited to by Mr. Parrado.
However, I likewise find no support for the proposition that Florida law encompasses the entirety of the standard of care in the State of Florida.
Here, Mr. Parrado testified that Florida pharmacists are required to take thirty hours of continuing education every two years, and that two of those hours have to be on the . . . opioid abuse and resolving red flags. Tr. 413. In this case, I find that Florida state law can be reasonably interpreted to support both Dr. Hamiltons and Mr. Parrados testimony.
Mr. Parrados testimony would generally be credited as to the governing laws and regulations within the Florida Pharmacy Act and the Florida Administrative Code. And Dr.
Hamiltons testimony would generally be credited as to the usual course of existing pharmacy practice. However, individual scrutiny will be given to the sections of the Florida Administrative GG Sentence 55 Fla.

E:FRFM01OCN2.SGM

was relocated for clarity.
Stat. 465.001 et seq.

01OCN2

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Federal Register - October 1, 2021

TítuloFederal Register

PaísEstados Unidos de América

Fecha01/10/2021

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